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The effects of prenatal vitamin D supplementation on child health
ISRCTN ISRCTN68645785
DOI 10.1186/ISRCTN68645785
ClinicalTrials.gov identifier
EudraCT number
Public title The effects of prenatal vitamin D supplementation on child health
Scientific title Effects of prenatal vitamin D supplementation on respiratory and allergic phenotypes and bone density in the first three years of life
Acronym N/A
Serial number at source 8325
Study hypothesis Asthma is the commonest chronic disease of childhood in the United Kingdom. In a recent study the prevalence of asthma in the UK was 20.9% in children aged 6 - 7 years, and 24.7% in young people aged 13 - 14 years old. Asthma is not curable once it has developed, and in most cases has its origins in early childhood. There is a justified focus on understanding the early life origins of asthma, with a view to developing primary prevention strategies.

This is a follow up study of a previously conducted randomised controlled trial (entitled 'Vitamin D deficiency and supplementation during pregnancy'). In that study, 180 mothers attending antenatal clinic at St Marys hospital were randomised at 27 weeks gestation to either no vitamin D (n = 60), 800 IU of vitamin D daily for the remainder of pregnancy (n = 60) or a single oral dose of 200,000 IU vitamin D at 27 weeks gestation.
Lay summary Not provided at time of registration
Ethics approval St Marys Hospital REC approved on the 11th March 2010 (ref: 10/H0712/13)
Study design Single centre randomised interventional prevention trial
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics
Participants - inclusion criteria All of the offspring of the 180 mothers recruited in the Vitamin D deficiency and supplementation during pregnancy trial are eligible and are invited to participate in this follow up study when their children are 3 years of age.
Participants - exclusion criteria Severe congenital or developmental abnormalities likely to significantly affect respiratory health or lung function, e.g., congenital thoracic dystrophy.
Anticipated start date 01/03/2010
Anticipated end date 31/05/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned sample size: 180; UK sample size: 180
Interventions 1. Control group: women received no vitamin D supplementation (n = 60)
2. Daily Vitamin D: women received 800 IU of vitamin D (ergocalciferol) daily from 27 weeks gestation until delivery (n = 60)
3. Stat Vitamin D: women received a single stat dose of 200,000 IU vitamin D (calciferol) at 27 weeks gestation (n = 60)

Study entry: single randomisation only
Primary outcome measure(s) Percentage (%) of children with any wheezing episode in the first 3 years of life, measured at 36 - 48 months
Secondary outcome measure(s) All measured at 36 - 48 months:
1. % of children using inhaled bronchodilators in the last 12 months
2. % of children with doctor diagnosed rhinitis
3. % of children with any wheezing episode in the preceding 12 months
4. % of children with doctor diagnosed asthma
5. % of children with doctor diagnosed eczema
6. % of children with doctor diagnosed food allergy
7. % of children with positive skin prick test responses
8. 25-hydroxyvitamin D levels
9. Bronchodilator responsiveness
10. Exhaled nitric oxide level (in parts per billion)
11. Nasal secretions for inflammatory mediators
12. Pulmonary airflow resistance and reactance at a range of frequencies using impulse oscillometry
13. Total number of all wheezing episodes since birth
14. Total number of upper and lower respiratory tract infections since birth
Sources of funding Asthma UK (UK)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23826104
Contact name Dr  Stephen  Goldring
  Address Department of Paediatrics
Wright-Fleming Institute
Norfolk Place
  City/town London
  Zip/Postcode W2 1PG
  Country United Kingdom
  Email sgoldring@nhs.net
Sponsor Imperial College London (UK)
  Address South Kensington Campus (Main Campus)
Imperial College
  City/town London
  Zip/Postcode SW7 2AZ
  Country United Kingdom
  Sponsor website: http://www3.imperial.ac.uk/
Date applied 24/06/2010
Last edited 10/03/2014
Date ISRCTN assigned 24/06/2010
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